Spots Global Cancer Trial Database for The National CT Colonography Trial
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Trial Identification
Brief Title: The National CT Colonography Trial
Official Title: The National CT Colonography Trial: Multicenter Assessment of Accuracy for Detection of Large Adenomas and Cancers in a Healthy Screening Population
Study ID: NCT00084929
Conditions
Interventions
Study Description
Brief Summary: RATIONALE: New diagnostic procedures such as computed tomographic colonography may improve the ability to detect colorectal cancer and may provide a less invasive method of detection. PURPOSE: This clinical trial is studying how well computed tomographic colonography works in screening healthy participants for colorectal cancer.
Detailed Description: OBJECTIVES: Primary * Compare the sensitivity of computed tomographic colonography (CTC) vs colonoscopy for detecting significantly large lesions (≥ 10 mm in diameter) in asymptomatic participants, in terms of specificity, area under the ROC curve, and predictive values for detecting clinically significant colorectal neoplasia. Secondary * Determine the interobserver variation in accuracy of interpreting CTC examinations of these participants, including any benefits of a primary 3-dimensional read and/or independent second interpretations. * Determine the effects of different colon preparations on the accuracy of CTC in these participants. * Compare participant acceptance and willingness to have a repeat examination by CTC vs colonoscopy. * Determine the accuracy of CTC in detecting flat lesions in the colon of these participants. OUTLINE: This is a multicenter study. Participants receive an oral laxative, oral bisacodyl, and three doses of oral barium sulphate 24 hours before imaging. After cathartic cleansing, participants undergo computed tomographic colonography followed by colonoscopy. Participants are followed up for approximately 4 weeks. PROJECTED ACCRUAL: A total of 2,607 participants will be accrued for this study.
Keywords
Eligibility
Minimum Age: 50 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: Yes
Locations
Mayo Clinic Scottsdale, Scottsdale, Arizona, United States
Moores UCSD Cancer Center, La Jolla, California, United States
Jonsson Comprehensive Cancer Center at UCLA, Los Angeles, California, United States
Veterans Affairs Medical Center - San Francisco, San Francisco, California, United States
Invision/Radiology Imaging Associates - Englewood, Englewood, Colorado, United States
Yale Cancer Center, New Haven, Connecticut, United States
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Clinical Radiologists, S.C. at Memorial Medical Center, Springfield, Illinois, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States
Mayo Clinic Cancer Center, Rochester, Minnesota, United States
Mallinckrodt Institute of Radiology at Washington University Medical Center, Saint Louis, Missouri, United States
M.D. Anderson Cancer Center at University of Texas, Houston, Texas, United States
Virginia Commonwealth University Massey Cancer Center, Richmond, Virginia, United States
Contact Details
Name: C. Daniel Johnson, MD
Affiliation: Mayo Clinic
Role: STUDY_CHAIR
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